Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug.

The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without comorbidities like hypertension, type 2 diabetes or dyslipidemia. The company says that there is no restriction on how long the drug can be used in weight management.

“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring this new prescription product to the millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery or stimulants,” Yishai Zohar, founder and CEO of Gelesis, said in a press release. “With Plenity, Gelesis is introducing a completely new approach with a unique mechanism of action to aid in weight management, with efficacy and safety supported by positive data from large clinical studies.”

The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis.

The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, the FDA had cited concerns with quality control, dosing, and a lack of information to support sex-based differences in efficacy.

Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients.

Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. Insulin list prices regularly increase by double digits annually, according to the FDA, which attributed the price hikes to a lack of competition.

Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month.

The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor.

Medtronic (NYSE:MDT) responded to a study presented this week which highlighted usability concerns with its MiniMed 670G automated insulin pump, writing that the company had “made many enhancements to the system since the study was done which would likely mitigate many of the issues experienced.”

Earlier this week, physicians from Boston Children’s Hospital reported that nearly one-fifth of participants in a real-world study of the MiniMed 670G stopped using the system within months of it being prescribed, citing dissatisfaction with the technical demands of the system.

Data from an 83-person study of Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop insulin pump showed that nearly one-fifth of participants stopped using the device after struggling with the technical demands of the system, researchers reported.

Medtronic’s MiniMed 670G device is designed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every five minutes and automating the administration of insulin.

Dyve Bioscience this week touted data from a human proof-of-concept pilot study of its transdermal sodium bicarbonate therapy for pain reduction in people with acute gout flare.

The study enrolled 24 people with a history of gout. Those in the active treatment group were given lotion containing sodium bicarbonate and menthol, while those in the placebo group were given lotion without sodium bicarbonate or menthol. Investigators told the participants to report to the clinic within 36 hours of flare onset.

Novocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer.

The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and quality of life.

We are saddened to share the news of the passing of Dr. Yves Cotrel. A pioneer in modern spine surgery, Dr. Cotrel's company Sofamor, was the foundation for what would become Medtronic Spine. Dr. Cotrel's contributions will live on for years to come. Condolences to his family. pic.twitter.com/JJ1Z…

The 44th edition of Arab Health is officially now open. #ArabHealth2019 runs until the 31st of January 2019 at the Dubai World Trade Centre and the Conrad Dubai from 10 am to 6 pm. Find out more on our website or download the Arab Health 2019 show app: bit.ly/2n3Z5Qpic.twitter.com/oasI…

Cancer is not a ‘one size fits all,’ nor is the way we treat it. We are working to better understand the different ways a cancer can mutate so we can discover new approaches to treat some of the most difficult-to-treat types of the disease. #ReimagineMedicine#ESMO18pic.twitter.com/41QL…

With #CARTcell therapy, an inactive virus programs T cells with new genetic information to help recognize specific antigens found on normal cells and certain blood cancer cells. As the CAR-T cells multiply, new copies also gain this ability. #CARTCellStorypic.twitter.com/Xuoh…

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